Randomised, double blind, Phase 2 Trial to evaluate the efficacy of oral Capsaicin in patients with post-stroke dysphagia in the (sub-)acute setting.
After inclusion and the assessment of the swallowing function (PRESS, PAS, FOIS, FEES) patients will be randomised 1:1 to receive 1mcg Capsaicin or Placebo. Oral treatment will be applied 3 times daily either during meals or during regular swallowing tests/trainings accompanied by a Speech Language Pathologist. After re-assessment of the dysphagia after 7 days, patients with persistent dysphagia and applicable for further treatment will be treated for another 23 days with a final clinical swallowing evaluation after a total of 30 days. A Patient Medication Diary will used during the Duration of the Trial to capture compliance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
82
Capsaicin 1.0 micrograms/ml
glycerol based suspension vehicle
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
RECRUITINGPenetration Aspiration Scale (PAS) score
the between-group difference of the Penetration Aspiration Scale (PAS) assessed with functional endoscopic evaluation of swallowing (FEES) 7 days after admission.
Time frame: 7 days after randomisation
Functional Oral Intake Scale (FOIS) score
Between group differences (capsaicin / placebo) of Functional Oral Intake Scale (FOIS)
Time frame: at day 7 and 30 post admission
days of nasogastric tube feeding
Between group differences (capsaicin / placebo) of days of nasogastric tube feedings
Time frame: from randomisation until day 30
number of patients with Percutaneous endoscopic gastrostomy (PEG) tube placement
Between group differences (capsaicin / Placebo) of number of patients with PEG tube placement
Time frame: from randomisation until day 30
number of patients with aspiration pneumonia
Between group differences (capsaicin / Placebo) of number of patients with aspiration pneumonia
Time frame: from randomisation until day 30
Swallowing quality of life questionnaire (Swal-QoL) score
Between group differences (capsaicin / Placebo) of Swallowing quality of life questionnaire (Swal-QoL)
Time frame: from randomisation until day 30
Latency of the Swallowing reflex
Between group differences (capsaicin / Placebo) of Latency of the Swallowing reflex
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Time frame: from randomisation until day 30
modified Ranking Scale (mRS) score
Between group differences (capsaicin / Placebo) of modified Ranking Scale (mRS)
Time frame: from randomisation until day 30
Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake Score (FOIS) with supratentorial stroke
admission of patients with and without sensory deficits (only supratentorial strokes)
Time frame: after 7 and 30 days post admission
Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake with supra-infratentorial stroke
of patients with stroke localisation with respect to supra-infratentorial localisation and involvement of sensory/motor swallowing cortex with its connections
Time frame: after 7 and 30 days post admission